目的 利用近红外光谱分析技术和化学计量学方法对银杏叶分散片生产过程中的关键参数混合均匀性进行无损、快速分析, 以控制产品质量。方法 采集银杏叶分散片生产过程中初混、总混样品的近红外漫反射光谱(NIRDRS), 分别用定量分析模型、光谱标准偏差法结合光谱马氏距离法分析初混、总混样品的光谱, 监测混合均匀性, 同时实验室自制混合样品, 动态模拟混合过程进一步验证马氏距离法的可行性。结果 定量分析模型和光谱标准偏差法所得混合均匀性结果一致, 马氏距离法动态分析混合过程可行。结论 本方法快速、简便, 可用于银杏叶分散片生产过程中的混合过程在线或旁线分析。
Abstract
OBJECTIVE To establish a nondestructive and rapid analysis method to measure the critical parameter, mixing uniformity, in the production of Ginkgo leaf dispersible tablets in order to control the quality of products. METHODS The near-infrared diffuse reflectance spectroscopy (NIRDRS) spectra of the pre-mix and the total mixed Ginkgo leaf dispersible tablets (Wuhan Jianmin Suizhou Pharmaceutical Co., Ltd.) were obtained. The mixing uniformity of samples was monitored by quantitative analysis model and standard deviation method combined with the Mahalanobis distance method, respectively. Meanwhile, lab-made mixing samples and dynamic simulation mixing process were used to validate the feasibility of Mahalanobis distance method. RESULTS The RESULTS obtained from quantitative analysis model and standard deviation method were consistent with each other, and the Mahalanobis distance method was feasible for monitoring the mixing process.CONCLUSION The method is rapid, simple, and can be used for online and sideline analysis in drug production process.
关键词
近红外漫反射光谱 /
过程分析 /
混合均匀性 /
银杏叶分散片
{{custom_keyword}} /
Key words
near-infrared diffuse reflectance spectroscopy /
process analysis /
mixing uniformity /
ginkgo leaf dispersible tablets
{{custom_keyword}} /
中图分类号：
R284
{{custom_clc.code}}
({{custom_clc.text}})
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] WANG X L, JIA J Z, YANG X, et al. Rapid determination of ibuprofen sustained-release capsule releasing rate using near infrared transmission spectroscopy technology. Chin J Pharm Anal(药物分析杂志), 2012, 32(10):1898-1902. [2] GAO H B, LIU H, QU L B, el al. Analysis of paracetamol and pseudoephedrine hydrochloride tablets by NIR. Chin J Pharm(中国医药工业杂志), 2009, 40(6):447-449. [3] ZHENG H J, HANG Y. Establishment of near infrared qualitative model for Tongxinluo Capsules. Chin Pharm Affa(中国药事), 2011, 25(4):373-374. [4] CHEN B, LI J H, ZHANG P, et al. The rapid detection of the quantitative indicators in LiuWeiDiHuang Pills by the near infrared spectroscopy. Lishizhen Med Mater Res(时珍国医国药), 2010, 21(5):1064-1066. [5] XU C Y, YE Z L, LI D K, et al. Rapid analysis of paeoniflorin in paeonia lactiflora extracts by near infrared transmittance spectroscopy. Chin J Exp Tradit Med Form(中国实验方剂学杂志), 2012, 18(17):134-137. [6] BODSON C, DEW`E W, HUBERT P H, et al. Comparison of FT-NIR transmission and UV-vis spectrophotometry to follow the mixing kinetics and to assay low-dose tablets containing riboflavin. J Pharm B, 2006, 41(3):783-790. [7] JIN Y, WU Y J, LIU X S, et al. Rapid and quantitative dtermination of multiple quality indicators (Indole alkaloids, etc. ) in concentration process of cantor extract using Fourier transform near infrared spectroscopy and chemometrics. Chin Pharm J(中国药学杂志), 2012, 47(9):712-717. [8] WU H Q, TAWAKKUL M, WHITE M, et al. Quality-by-Design (QbD): An integrated multivariate approach for the component quantification in powder blends. Int J Pharm, 2009, 372: 39-48. [9] CHEN C, LI W L, QU H B, et al. An on-line near-infrared spectroscopy approach for content determination in the perolation process of compound Kushen injecton. Chin Pharm J(中国药学杂志), 2012, 47(21):1689-1702. MOES J J, RUIJKEN M M, GOUT E, et al. Application of process analytical technology in tablet process development using NIR spectroscopy: Blend uniformity, content uniformity and coating thickness measurements . Int J Pharm, 2008, 357:108-118. ZHANG Y Y, ZHANG J W, LIU Y. Application of on-line quality control for paeoniflorin extraction by NIRS. Chin J Pharm(中国医药工业杂志), 2010, 41(9): 662-665. LUAN L J, CHEN N, LIU X S, et al. Rapid analysis of purification process of Grape Seed extracts using near infrared spectroscopy. Chin J Anal Chem(分析化学), 2009, 40(4): 626-629. XUE Y P, YAO T W, JIANG J W. HPLC Fingerprint of the tablets of Ginko biloba L. . J Zhejiang Univ(Med Sci)(浙江大学学报:医学版), 2004, 33(1):24-28. WANG Y, YANG Y F. The research of Ginkgo biloba pharmacology. Chin J Mod Appl Pharm(中国现代应用药学杂志), 2001, 18(1):1-3. WU X M, YIN B Z. The determination methods of Ginkgo biloba flavones. Chin J Pharm Anal(药物分析杂志), 2001, 21(2):138-140.
{{custom_fnGroup.title_cn}}
脚注
{{custom_fn.content}}
PDF(3046 KB)
